Hypoactive Sexual Desire Disorder (HSDD) Drug Expecting FDA approval in June

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Hypoactive Sexual Desire Disorder (HSDD) is the most common form of sexual dysfunction in the United States, affecting up to a third of adult women. HSDD is characterized by a low sexual desire and lack or absence of sexual fantasies and can be considered a sexual dysfunction if it results in significant distress and interpersonal difficulties.

Bremelanotide is a drug under the brand name Vyleesi that was recently put into production by Amag Pharmaceuticals to treat women diagnosed with HSDD. Many medical and pharmaceutical experts expect the drug to be a success.


In 2015, the FDA approved a medication under the brand name Addyi (flibanserin) produced by Sprout Pharmaceuticals to treat HSDD. However, the drug has not been experiencing as much success as anticipated.

Makers of the drug faced several significant safety-related charges that reduced its uptake. The Risk and Evaluation Mitigation Strategy (REMS) program was put in place to ensure that the benefits of the drug outweigh its risks and found that there was an alcohol use contraindication on the drug’s label.


Bremelanotide is expected to be more successful than flibanserin for several reasons, the first of which is that the former is not expected to pose the same health and safety risks as the latter. Second, bremelanotide was tested in clinical drug trials and was reported to successfully manage nausea side effects. Finally, despite bremelanotide’s subcutaneous mode of administration via injection, the drug can be administered on an as-needed basis, as opposed to flibanserin, which must be taken daily.

Addyi’s conflict with alcohol found by the REMS program has significantly worsened the drug’s performance on the market. Conversely, bremelanotide—also known as Vyleesi—is expected to be approved by the FDA in June and should be available on the market shortly after.

Bremelanotide is meant to be used as needed or 45 minutes before sexual activity. Over 90 percent of women in Phase III studies found the self-injectable pen easy to use and reported no significant issues with the fine-gauge needle.

Contact Dr. Jacobson Today About HSDD

If you or your loved one is experiencing signs of HSDD and would like more information about the condition and potential remedies, please contact Dr. Edward Jacobson today and schedule a free consultation.